Show:
VARIOUS CATEGORIES OF UNITED STATES LAW
MONOGRAPH REQUIREMENTS
REGULATORIY AGENCIES
laws and amendments that affect the practice of pharmacy.
ETHICS
100
CONSTITUTIONAL LAW
Overrides all other laws—if a state law is ruled “not legal” under the constitution (whether federal or state), it is not legal
100
Monographs
• Commonly known as package inserts • A necessary component of drug labeling • Provides all the clinical information required by the FDA
100
Drug Enforcement Administration (DEA)
Regulates legal trade in narcotic and dangerous drugs • Manages national narcotics intelligence system • Works with other agencies to support drug traffic prevention • Shares jurisdiction over drug offenses with Federal Bureau of Investigation (FBI) • Agents of the two organizations work together on drug law enforcement • Administrator of the DEA reports to the director of the FBI
100
Pure Food and Drug Act of 1906
Provided for federal inspection of meat products • Forbade the manufacture, sale, or transport of adulterated food products or poisonous patent medicines • Ultimately proved to be inadequate because it did not: • Cover cosmetics • Provide the authority to ban unsafe drugs • Prohibit false statements about drugs • Require labeling to identify product contents
100
Ethics
• Derived from the Greek word ethos, referring to one’s character • Discipline of evaluating the merits, risks, and social concerns • Commonly defined as considered reflection or systematic analysis when required actions are unclear • Based on certain universal principles such as justice, doing no harm, etc. • Ethics are not morals, but can be influenced by personal morals
200
Statutes
laws passed by federal, state, or local legislatures • Regulations: clarify and explain statutes • Must be consistent with statute • Have the same power or authority as the statute
200
Components of a monograph
Description • Clinical Pharmacology • Indications and Usage • Contraindications • Warnings • Precautions • Drug Abuse and Dependence • Adverse Reactions • Dosage • How Supplied
200
Food and Drug Administration (FDA)
Responsible for protecting public health • Assures safety, efficacy, and security of: • Drugs • Biological products • Medical devices • Food • Cosmetics • Reviews/approves new drugs, generic equivalents, and therapeutic indications for existing medications
200
Food, Drug, and Cosmetic Act of 1938
Prompted by the sulfanilamide disaster of 1937 • Limited interstate commerce in drugs to those that are safe and effective • Established the Food and Drug Administration (FDA) • Regulated labeling of drugs • Regulated who could prescribe legend (prescription- only) drugs
200
Ethical decisions
• Not clear-cut, either/or, correct or incorrect (binary) decisions • Require a balance between a professional code of ethics and personal morals • Are not emotional reactions,but courses of conduct that have been weighed and measured carefully
300
State law and regulations
State constitutions establish the organization of state government • Must be consistent with federal statutes and regulations • State statutes and regulations may provide additional rights • States may not guarantee rights that are explicitly not constitutionally legal (e.g., drug possession) • States may not take away rights that are provided by federal law
300
Components of a monograph
Precautions Drug Abuse and Dependence Adverse Reactions Dosage How Supplied
300
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
Evaluates and accredits nearly 15,000 healthcare organizations and programs • Establishes and enforces standards that improve quality and safety of healthcare organizations • Evaluates and accredits: • Hospitals • Hospice facilities • Nursing homes • Long-term-care facilities • Rehabilitation centers • Other healthcare organizations
300
Durham-Humphrey Amendment of 1951
Also known as the Prescription Drug Amendment • Required prescription drugs to bear the legend, “Caution: Federal law prohibits dispensing without a prescription.” • Later amendments approved a substitute legend that reads “RX only.”
300
Moral philosophy
• An individualized set of values or value system • The reasoning process that defines the subjective rightness or wrongness of conduct
400
Legislative intent
The “meaning” of a law is based on its intent • Legal interpretation is based on: • Words such as “may” and “shall” (“may” means optional,“shall” means required) • Punctuation (a comma may imply connected intent; a semicolon may imply a separate intent) • Commonly influenced by “case law,” as intent may be determined or refined when a law is challenged in court
400
Occupational Safety and Health Administration (OSHA)
• Division of the U.S. Department of Labor • Assures the safety and health of American workers by setting and enforcing protective standards • Enforces occupational safety standards in all 50 states • Provides technical assistance and consultation programs
400
Comprehensive Drug Abuse Prevention and Control Act of 1970
Also known as the Controlled Substances Act of 1970 • Combined all federal laws dealing with narcotics, stimulants, depressants, and abused designer drugs • Established the Drug Enforcement Administration (DEA) • Established five “classes” or schedules for controlled substances
400
ETHICS
Based on certain universal principles such as justice, doing no harm, etc. Ethics are not morals, but can be influenced by personal morals
500
Criminal laws
Deal with homicide, illegal drugs, theft, and other antisocial behavior • Enforced by state agents against specific persons or corporations • Crimes are considered harmful actions against society, rather than an individual • Criminal cases are thus titled State v. John Smith
500
State Board of Pharmacy (SBOP)
State agency that registers and regulates: • Pharmacy facilities • Pharmacists • Pharmacy technicians • Responsible for the actual practice of pharmacy within state domain • Granted the authority to monitor, reprimand, and revoke licensures
500
Kefauver-Harris Amendment of 1962
Prompted by the thalidomide disaster of 1962 • Also known as the Drug Efficacy Amendments • Focused on accountability from drug manufacturers for the effectiveness of drugs • Manufacturers required to supply proof of effectiveness and safety • Advertising of prescription drugs placed under the supervision of the FDA • Established procedures for new drug applications
500
Practicing Ethical and/or Moral Behavior
Beneficence—bringing about good Fidelity—keeping a promise Veracity—telling the truth Justice—acting with fairness or equity within the law Autonomy—acting with self-reliance